BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 14.0MM THREAD/100MM

    MDR report key: 4220020 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14439
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROXIMAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2014. THE DYNAMIC HIP SCREW COUPLING SCREW BROKE INSIDE OF THE DYNAMIC HIP SCREW LAG SCREW WHEN THE SURGICAL TECHNICIAN WAS TESTING THEM. THE TEST OCCURRED ON THE STERILE FIELD ON THE BACK TABLE OF THE OPERATING ROOM. ANOTHER COUPLE SCREW AND LAG SCREW WERE READILY AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT HARM AND SURGICAL DELAY. SCREWS ARE NOT AVAILABLE FOR RETURN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703840 DHS®/DCS® LAG SCREW 14.0MM THREAD/100MM APPLIANCE,FIXATION,NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1